(114 days)
Not Found
No
The summary describes a standard electronic measurement device for lung function with data storage and transmission capabilities. There is no mention of AI or ML algorithms being used for data analysis, interpretation, or prediction. The "traffic lights" indication is based on physician-defined criteria, not learned patterns.
No
This device is an electronic measurement device used to monitor lung function and respiratory status, specifically measuring flow and calculating parameters like FEV1. It serves a diagnostic and monitoring purpose, but it does not provide treatment or intervene therapeutically in any way.
Yes
The device is described as an "electronic measurement device to monitor the lung function (determination of the respiratory flows and volume)" and is "used to monitor the respiratory status of human beings in the areas asthma, chronic obstructive pulmonary disorder". It measures parameters like FEV1 and PEF and provides results to the patient. This aligns with the definition of a diagnostic device, which is used to detect or monitor a disease.
No
The device description explicitly states it is a "Handheld device" and includes physical components like a "Flow sensor" and "Mouthpiece," indicating it is a hardware device with integrated software.
Based on the provided text, the Asthma Monitor AM3 / AM3 BT is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- Asthma Monitor Function: The Asthma Monitor AM3 / AM3 BT measures respiratory flows and volume directly from the patient's breath (an in vivo measurement), not from a specimen taken from the body. It monitors lung function by measuring parameters like PEF and FEV1.
Therefore, while it is a medical device used for monitoring a medical condition, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Asthma Monitor AM3 / AM3 BT from Cardinal Health is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever and whenever is a need of. The AM3 / AM3 BT measures the flow during expiration serving for the calculation of further parameters as FEV1.
The AM3 / AM3 BT is used to monitor the respiratory status of human beings in the areas asthma, chronic obstructive pulmonary disorder and in areas like occupational medicine, clinical trials and disease management.
The patient is informed of the results by numeric values for selected parameters (e.g. PEF, FEV1). Furthermore a visual control unit, displayed as a kind of traffic lights, allows an immediate indication of the measurement based on criteria defined by the patient's physician.
The device saves the results of a measurement (always with date and time) automatically in an internal database. The memory capacity is designed to store up to 400 measurements. In addition, a questionnaire functionality can be called up by the use of a software package (AMOS) to record e.g. the "Quality of Life" status. When enabled, the AM3 / AM3 BT can be programmed with a couple of questions, where the patient can select then from a couple of different answers. This information is also stored in the internal database and can be transmitted for evaluation to a standard PC using the software package AMOS.
The AM3 / AM3 BT is designed to replace ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the Asthma Monitor AM3 / AM3 BT being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine.
Product codes (comma separated list FDA assigned to the subject device)
BZG
Device Description
The Asthma Monitor AM3 is a medical device (peak flow meter with symptom diary) providing following characteristics:
- Handheld device
- Battery operation
- Storing capacity of 400 measurements
- Storing capacity of 200 sets of questionnaires (each 12)
- Measurement Parameters: PEF and FEV1
- Accuracy Flow: ± 5% or ± 20 l/min
- Accuracy Volume: ± 3% or ± 0.05 liter
- Data transmission to computer via USB, Bluetooth and Serial
- Flow sensor (single patient use)
- Mouthpiece (single patient use)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung function
Indicated Patient Age Range
The Asthma Monitor can be used for patients from 4 years on and older.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following practices were followed and monitored for development of the Asthma Monitor AM3 with the Bluetooth data transmission:
- The Bluetooth data transmission for the above device was developed in accordance with the Cardinal Health development standard operating procedures (000490 09 - Design Control).
- The risk analysis method used to assess the impact of Asthma Monitor AM3 with the additional Bluetooth data transmission was a Failure Modes and Effects Analysis (FMEA).
- Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards.
- The EMC testing was performed according EN 60601-1-2.
- The software was developed according to the IEC 601-1-4 Standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).
0
K0928&J
510(k) Summary
JAN 1 3 2010
GENERAL INFORMATION
5.1 Type of Submission
Special 510(k) Submission
Submission date: 09/03/2009
5.2 Submitter
Name:
CareFusion Germany 234 GmbH (formerly: Cardinal Health Germany 234 GmbH)
Address:
Phone:
FAX:
Leibnizstrasse 7 D-97204 Hoechberg Germany
Contact person in Germany:
Address:
Elmar Niedermeyer CareFusion Germany 234 GmbH Leibnizstrasse 7, 97204 Hoechberg Germany +49 931 49 72 - 361 +49 931 49 72 - 62361 Elmar. Niedermeyer@carefusion.com
Contact person in the U.S .: (Official Correspondent) Thomas Gutierrez Address
Phone/Fax:
CareFusion 22745 Savi Ranch Parkway Yorba Linda, CA 92887 714-919-3342 Thomas. Gutierrez@carefusion.com
. -
1
- 5.3 Establishment Registration Number 9615102
- Common Name or Classification Name 5.4 Diagnostic Spirometer (CFR 868.1840, Product Code BZG)
5.5 Trade Name Asthma Monitor AM3 / AM3 BT
- 5.6 Device Classification This is a Class II device
5.7 Classification Panel
73 Anesthesiology Part 868 Code BZG
5.8 Reason for Premarket Notification
Device modification to an existing Cardinal Health - device regarding "The New 510(k) Paradigm" -- Additional data transfer to computer by blue tooth --
5.9 Legally predicate marketed device
Asthma Monitor AM3 K980676/A2 Code BZG
Asthma Monitor AM1+ / AM1+ BT K090486 Code BZG
Predicate Device Company 5.10
CareFusion Germany 234 GmbH (formerly: Cardinal Health Germany 234 GmbH)
Device Description 5.11
The Asthma Monitor AM3 is a medical device (peak flow meter with symptom diary) providing following characteristics:
- . Handheld device
- Battery operation ●
- Storing capacity of 400 measurements .
- Storing capacity of 200 sets of questionnaires (each 12) o
- Measurement Parameters: PEF and FEV1 ●
- Accuracy Flow: ± 5% or ± 20 l/min ●
- Accuracy Volume: ± 3% or ± 0.05 liter ●
- Data transmission to computer via USB, Bluetooth and Serial .
- Flow sensor (single patient use)
- Mouthpiece (single patient use) .
2
5.12 Intended Use Statement
The Asthma Monitor AM3 / AM3 BT from Cardinal Health is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever and whenever is a need of. The AM3 / AM3 BT measures the flow during expiration serving for the calculation of further parameters as FEV1.
The AM3 / AM3 BT is used to monitor the respiratory status of human beings in the areas asthma, chronic obstructive pulmonary disorder and in areas like occupational medicine, clinical trials and disease management.
The patient is informed of the results by numeric values for selected parameters (e.g. PEF, FEV1). Furthermore a visual control unit, displayed as a kind of traffic lights, allows an immediate indication of the measurement based on criteria defined by the patient's physician.
The device saves the results of a measurement (always with date and time) automatically in an internal database. The memory capacity is designed to store up to 400 measurements. In addition, a questionnaire functionality can be called up by the use of a software package (AMOS) to record e.g. the "Quality of Life" status. When enabled, the AM3 / AM3 BT can be programmed with a couple of questions, where the patient can select then from a couple of different answers. This information is also stored in the internal database and can be transmitted for evaluation to a standard PC using the software package AMOS.
The AM3 / AM3 BT is designed to replace ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the Asthma Monitor AM3 / AM3 BT being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational
medicine.
· 5.13 · Required Components AM3 / AM3 BT measurement device Accessories User Manual
3
5.14 Summary Table of Comparison
a) Comparison with Asthma Monitor AM3 with 510(k) K980876/A2
| | Asthma Monitor AM3
(K980876/A2) | Asthma Monitor AM3
with Bluetooth |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Indications
for Use | The Asthma Monitor AM from
Cardinal Health is an electronic
measurement device to monitor the
lung function (determination of the
respiratory flows and volume) with
high reproducibility wherever and
whenever is a need of. The AM
measures the flow during expiration
serving for the calculation of further
parameters as FEV1.
The AM is used to monitor the
respiratory status of human beings in
the areas asthma, chronic obstructive
pulmonary disorder and in areas like
occupational medicine, clinical trials
and disease management.
The patient is informed of the results
by numeric values for selected
parameters (e.g. PEF, FEV1).
Furthermore a visual control unit,
displayed as a kind of traffic lights,
allows an immediate indication of the
measurement based on criteria
defined by the patient's physician.
The device saves the results of a
measurement (always with date and
time) automatically in an internal
database. The memory capacity is
designed to store up to 400
measurements. In addition, a
questionnaire functionality can be
called up by the use of a software
package (AMOS) to record e.g. the
"Quality of Life" status. When
enabled, the AM can be programmed
with a couple of questions, where the
patient can select then from a couple
of different answers. This information
is also stored in the internal database
and can be transmitted for evaluation
to a standard PC using the software
package AMOS.
The AM is designed to replace
ordinary peak flow meter, diary and
pencil by a single system. Easy
handling, sturdy and handy design
allow the Asthma Monitor AM being
used almost everywhere: at work, at
home, in school, for experts opinion,
research or clinical trial purposes and | identical |
| Patient
population | The Asthma Monitor can be used for
patients from 4 years on and older. | identical |
| Dimensions
(housing) | Length x Width x Height:
1128237 mm
Weight:
167 g (batteries included) | identical |
| Display | LCD module
Size: 54,0 x 33,5 mm
255 x 160 dots | identical |
| Key-panel | Foil Key-panel (4 keys):
- ESC (on/off)
- UP-ARROW
- DOWN-ARROW
- OK | identical |
| Integrated
mouthpiece
(material) | Polysterol 454C | identical |
| Single Use
mouthpiece
(material) | Bormed RG835 MO | identical |
| Performance
(measurements) | Parameters:
PEF
FEV1 | identical |
| Interface | Serial RS 232 & USB | Serial RS 232 & USB & Blue-
tooth |
| Energy type | 3 x 1,5 (Micro AAA) | identical |
| Operating
Require-
ments | PC software AMOS | identical |
| | Asthma Monitor AM1+
/ AM1+ BT K090486 | Asthma Monitor AM3
with Bluetooth |
| Bluetooth
interface | WML-C46 (Manufactured by
Mitsumi Electric Co. LTD) | Identical |
| Bluetooth
Power
Supply | 3.3 Vdc | Identical |
| Bluetooth
Transmit
Power | 2.65 dBm E.I.R.P. | Identical |
| Bluetooth
Frequency
Range | 2.402GHz - 2.480GHz | Identical |
| Bluetooth
Modulation
Technique | Frequency Hopping Spread
Spectrum (FHSS) (GFSK) | Identical |
| Bluetooth
Number of
Channels | 79 | Identical |
| Bluetooth
Dwell Time |